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Pegvisomant

Phase 3

Acromegaly | Small molecule | Endocrine |Pfizer, Inc.|Last Updated: Jan 5, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Pegvisomant · 2 trials · 2 indications

Phase 3 1Phase 1 1
NCT00143416Long Term Study With B2036-PEGAcromegaly
COMPLETED16 Analytics
PHASE3COMPLETED
Long Term Study With B2036-PEG
AcromegalyUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the safety and efficacy of long-term B2036-PEG therapy in patients with acromegaly
The area under the pegvisomant concentration-time curve from time 0 to infinity hours post dose (AUCinf)
16 days
The area under the pegvisomant concentration-time curve from time 0 to last observed timepoint (AUClast)
16 days

Secondary Endpoints

PK/PD evaluation
Maximal pegvisomant concentration (Cmax)
16 days
The timepoint at which Cmax is obtained (Tmax)
16 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment sequence #1ACTIVE_COMPARATOROne 1-mL subcutaneous injection at 30 mg/mL in Period 1 and two 1-mL subcutaneous injections at 15 mg/mL each in Period 2
Treatment sequence #2ACTIVE_COMPARATORTwo 1-mL subcutaneous injections at 15 mg/mL each in Period 1 and one 1-mL SC injection at 30 mg/mL in Period 2

Interventions

NameTypeDescription
PegvisomantDRUG -
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Eligibility Criteria

Age Range20 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Patients with acromegaly who have received at least one dose of B2036-PEG in the preceding study (A6291009). Exclusion Criteria: * Switching to other therapeutic methods for acromegaly

Countries:JapanSingapore
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Frequently asked questions about Pegvisomant

What is Pegvisomant used for?

Pegvisomant is used for the treatment of acromegaly, a condition of excess growth hormone. It has been studied in a Phase 3 clinical trial for acromegaly in Japan. The drug is also being investigated for bioavailability in healthy subjects.

Who makes Pegvisomant?

Pegvisomant is developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is the developer of this investigational drug for acromegaly.

What phase is Pegvisomant in?

Pegvisomant is in Phase 3 clinical development for acromegaly. It has completed a Phase 3 trial in Japan with 16 participants. The drug is investigational and not yet approved for marketing.

What clinical trials is Pegvisomant in?

Pegvisomant has been studied in two completed trials. NCT00143416 is a Phase 3 long-term study in acromegaly patients in Japan. NCT01181973 is a Phase 1 study of safety, tolerability, and relative bioavailability in healthy subjects in Singapore.

Is Pegvisomant the same as B2036-PEG?

Yes, Pegvisomant is also known as B2036-PEG. The Phase 3 clinical trial for acromegaly, NCT00143416, is titled 'Long Term Study With B2036-PEG' and evaluates this drug in patients with acromegaly.